BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART LUNG MACHINE

    MDR report key: 24647834 · Received March 20, 2026

    Report

    Report Number
    8010762-2026-0000135
    Event Type
    Malfunction
    Date Received
    March 20, 2026
    Date of Event
    March 13, 2026
    Report Date
    March 20, 2026
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    KFM
    UDI-DI
    04037691718910
    PMA / PMN Number
    K991864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING. FURTHER INFORMATION HAS BEEN REQUESTED BUT HAS NOT YET BEEN RECEIVED. A FOLLOW UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. NOTE: THIS EVENT OCCURRED ON THE CHINESE MARKET. IT IS A SIGNIFICANTLY SIMILAR DEVICE TO "BASE UNIT, ROTAFLOW CONSOLE¿ WHICH IS SOLD IN THE USA UNDER PREMARKET SUBMISSION NUMBER K991864. FOR SECTION D4 ALL AVAILABLE IDENTIFYING INFORMATION IS FOR THE OUT OF THE US DEVICE, SUBJECTED TO THIS REPORT. THEREFORE, NO GUDID INFORMATION EXISTS. FURTHERMORE, UDI INFORMATION (PRIMARY DI NUMBER) PROVIDED IN D4 IS FOR ROTAFLOW CONSOLE WITH CATALOG NUMBER 701046405.

    Description of Event or Problem · 0

    THE EVENT OCCURRED IN CHINA. IT WAS REPORTED THAT THE ERROR MESSAGE ¿HEAD ERROR¿ OCCURRED ON THE ROTAFLOW CONSOLE AND THE ROTAFLOW DRIVE DURING PATIENT TREATMENT. THE DEVICE WAS REPLACED WITH ANOTHER MACHINE WITHOUT ANY NEGATIVE CONSEQUENCES FOR THE PATIENT. NO HARM TO ANY PERSON HAS BEEN REPORTED. SINCE THE DEVICE WAS EXCHANGED DURING PATIENT TREATMENT, WHICH STOPS TREATMENT FOR A MOMENT, THE EVENT CAN RESULT IN A RISK FOR HARM OF ANY PERSON. FURTHERMORE, THE REPORTED ¿HEAD ERROR¿ COULD LEAD TO A PUMP STOP DURING USE, THEREFORE A REPORT IS REQUIRED. COMPLAINT ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716710 HEART LUNG MACHINE PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM MAQUET CARDIOPULMONARY GMBH ROTAFLOW 04037691718910

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown